MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS PICC 3F WITH STIFFENING STYLET WIRE (SL) (65 CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reds2297 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported catheter was in use for 4 days until a crack was noted near by suture wing.No other information was provided.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a split is confirmed; however, the exact cause is unknown.One 3 fr single lumen per-q-cath catheter was returned for evaluation.An initial visual observation showed some use residue on the returned sample.A split was observed in the catheter just distal to the strain relief.Tensile weakness was observed in the returned catheter around the area of the split as well as just distal to it.A microscopic observation revealed the split was relatively large, curved, and mostly circumferential.An additional smaller and superficial split was observed adjacent to the larger split.The fracture surface was observed to be at a slight angle but flat, smooth, and granular in texture.While the exact cause of the splits observed in the returned catheter is unknown, based on the evidence observed on the returned sample, possible causes include over-pressurization and instrument damage.H3 other text: evaluation findings are in section h11.
Event or Problem Description
It was reported catheter was in use for 4 days until a crack was noted near by suture wing.No other information was provided.

• Brand Name: PER-Q-CATH PLUS PICC 3F WITH STIFFENING STYLET WIRE (SL) (65 CM)
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12580490
• Report Number: 3006260740-2021-04142
• Device Sequence Number: 3288512
• Product Code: LJS
• UDI-Device Identifier: 00801741074844
• UDI-Public: (01)00801741074844
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K954104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 4133105
• Device Lot Number: REDS2297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 12/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 5 YR
• Patient Sex: Female